Diabetes Mellitus, Type 2NCT02513277
Diabetes Screening & Prevention for People With Learning (Intellectual) Disabilities:STOP Diabetes Study
An observational study of Diabetes Mellitus, Type 2 and Prediabetic State, run by University of Leicester at 1 site in United Kingdom.
Trial summary
People with learning (intellectual) disabilities have more health problems than the rest of the population; they are less likely to access help and have lifestyles that may increase their risk of getting diabetes (for example, poor diet and lack of physical activity). Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetic State, Intellectual Disability
- How many people
- 930 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with a learning (intellectual) disability who are live in Leicester, Leicestershire or Rutland, UK;
Who may be able to join
- Volunteer has a confirmed learning disability (permanent intellectual impairment);
- Registered with a general practice in Leicester, Leicestershire or Rutland, UK;
- Participant and/or carer has sufficient English language skills to enable fully informed consent to be obtained.
Who cannot join
- Confirmed diagnosis of Type 2 diabetes or Type 1 Diabetes;
- Malignancy or terminal illness;
- Pregnancy or breast feeding;
- Severe systemic disease that may interfere with measurement and interpretation of HbA1c.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Research Centre, University of Leicester
Leicester, LE5 4PW
About this study
Official title: Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities
People with learning (intellectual) disabilities have more health problems than the rest of the population; they are less likely to access help and have lifestyles that may increase their risk of getting diabetes (for example, poor diet and lack of physical activity). People with learning disabilities may also be prescribed drugs or have certain medical conditions (such as Down's syndrome) which can make their chances of getting diabetes greater.
Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than normal but are not high enough to be diagnosed with diabetes. People with impaired glucose regulation are more likely to develop diabetes, heart disease and stroke in the future. If people with impaired glucose regulation make changes to their lifestyle (diet and exercise) they can prevent or delay getting diabetes.
The aim of this study is to screen people with learning disabilities for diabetes and impaired glucose regulation. The investigators also want to find out the best way to give people with learning disabilities some education around healthy lifestyles (for example, eating and exercise) to help with prevention of diabetes and cardiovascular disease. Therefore, the investigators also aim to develop a lifestyle education programme that is suitable for use in this population and test whether it is feasible and acceptable.
Read the detailed description
Background -Adults with learning (intellectual) disabilities tend to have more health problems than the general population and are less likely to access help. Additionally, evidence suggests that due to a combination of lifestyle factors (e.g. poor diet, lack of physical activity), associated medical problems, and certain types of prescribed medication, people with learning disabilities may be at increased risk of developing type 2 diabetes and cardiovascular disease. Our overall aim is to undertake a programme of research that improves our knowledge and understanding of screening for impaired glucose regulation and type 2 diabetes in a population with learning disabilities, and to develop a lifestyle education programme for prevention of type 2 diabetes that is suitable for use in this population.
SCREENING PROGRAMME
Aim - The main programme of work consists of a large diabetes screening programme. The primary aim of the screening study is to evaluate the feasibility and clinical and cost effectiveness of a screening programme for identifying undiagnosed type 2 diabetes and impaired glucose regulation that is suitable for use in a population with learning disabilities.
Methods - A variety of approaches will be used to recruit people to the screening study: General practices will be approached first for participation in this study. If the practice does not agree, then the investigators will seek to approach eligible people on the Leicestershire Learning Disabilities Register. Learning disabilities consultants will also approach people face to face when attending for outpatient clinic appointments. Additionally, if individuals with learning disabilities (and/or their carer) contact the STOP Diabetes team to express an interest in the study, they will be given an invitation.
- Volunteers will be asked to attend an appointment(s) where consent will be obtained and biomedical and demographic data collected. The consent process and data collection will be staged and people may need to attend between one to three appointments to complete.
- People who are found to have type 2 diabetes or impaired glucose regulation will be asked to see their GP for care.
- At every stage, reasonable adjustments will be made to take into account people's communication needs and decision making capacity. This may include involving a carer or a
DEVELOPMENT AND TESTING OF A STRUCTURED EDUCATION PROGRAMME
The aims of additional work being carried out alongside the screening study are to: (1) develop a lifestyle education programme to meet the needs of a population with learning disabilities and impaired glucose regulation or high risk of diabetes; (2) assess the feasibility of collecting outcome measures for participants with learning disabilities before and 3-months after they attend the education programme.
Methods - People approached to take part will be people who took part in the screening study and (1) gave their consent to be approached to take part in further phases of the research programme, and (2) were found to be at increased risk of developing diabetes according to their screening results.
Qualitative Interviews to inform curriculum development:
- Interviews will be conducted with a sample of people with mild/moderate learning disabilities, their carers and healthcare professionals. Findings from the interviews will help inform development of an initial curriculum and education program.
Delivery of initial curriculum and obtaining feedback:
- As part of the development work the education programme will be piloted with at least two groups of 6 - 8 people plus carers. Feedback will be collected from some of the people who attend the education sessions and any necessary changes made to the curriculum. These cycles of piloting, collecting feedback and modifying the programme will be repeated until the education programme developed is "fit for purpose".
Delivery of programme with collection of before and after measures:
- Following initial development, testing and refinement of the curriculum, the education programme will be delivered with another sample of participants and the feasibility of collecting pre and post intervention outcome measures will be tested. The investigators anticipate delivering the programme to up to two groups of 6 - 8 people plus carers. Data will be collected at baseline and 3-months (12 weeks) following delivery of the final education session. Data and may include: physical activity and sedentary behaviour (as measured by accelerometer); body weight, BMI, waist circumference, blood pressure and dietary intake (fruit and vegetables). Uptake of the education programme (attendance) and retention at 3-months follow-up will also be explored. This phase will be subject to modification depending on the findings from prior iterations and any problems encountered.
- Keywords
- type 2 diabetes, impaired glucose regulation, intellectual disability, learning disability, screening, prevention, lifestyle education
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Intellectual Disability, Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated haemoglobin (HbA1c)
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Measured: Baseline screening appointment
Plasma glucose
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Measured: Baseline screening appointment
Secondary outcomes (10)
Physical activity levels (including sedentary behaviour)
measured by accelerometer - only for a small sub-group
Measured: Baseline screening appointment
Obesity levels
body mass index and waist size
Measured: Baseline screening appointment
Blood pressure
systolic and diastolic
Measured: Baseline screening appointment
Lipids levels
total cholesterol, LDL, HDL, triglycerides
Measured: Baseline screening appointment
Dietary/nutritional intake
food groups and fruit and vegetable intake
Measured: Baseline screening appointment
Cardiovascular risk
Framingham risk score
Measured: Baseline screening appointment
Health related quality of life
EQ-5D
Measured: Baseline screening appointment
Behavioural disorders
Aberrant Behaviour Checklist
Measured: Baseline screening appointment
Psychiatric disorders
PAS-ADD checklist
Measured: Baseline screening appointment
Depression
Glasgow Depression Scale and Carer Supplement
Measured: Baseline screening appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startFeb 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Kamlesh Khunti, PhD, FRCGP, Principal investigator, Diabetes Research Centre, University of LeicesterProf Sabyasachi Bhaumik, FRCPsych, Principal investigator, Learning Disability Service, Leicester Partnership NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513277
- Sponsor's protocol ID
- 0341
- Other IDs
- RP-PG-1209-10057
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2015
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities
- ClinicalTrials.gov ID
- NCT02513277
- Acronym / sponsor ID
- 0341
- Keywords
- type 2 diabetes, impaired glucose regulation, intellectual disability, learning disability, screening, prevention, lifestyle education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with learning (intellectual) disabilities have more health problems than the rest of the population; they are less likely to access help and have lifestyles that may increase their risk of getting diabetes (for example, poor diet and lack of physical activity). People with learning disabilities may also be prescribed drugs or have certain medical conditions (such as Down's syndrome) which can make their chances of getting diabetes greater.
Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than normal but are not high enough to be diagnosed with diabetes. People with impaired glucose regulation are more likely to develop diabetes, heart disease and stroke in the future. If people with impaired glucose regulation make changes to their lifestyle (diet and exercise) they can prevent or delay getting diabetes.
The aim of this study is to screen people with learning disabilities for diabetes and impaired glucose regulation. The investigators also want to find out the best way to give people with learning disabilities some education around healthy lifestyles (for example, eating and exercise) to help with prevention of diabetes and cardiovascular disease. Therefore, the investigators also aim to develop a lifestyle education programme that is suitable for use in this population and test whether it is feasible and acceptable.
Detailed description
Background -Adults with learning (intellectual) disabilities tend to have more health problems than the general population and are less likely to access help. Additionally, evidence suggests that due to a combination of lifestyle factors (e.g. poor diet, lack of physical activity), associated medical problems, and certain types of prescribed medication, people with learning disabilities may be at increased risk of developing type 2 diabetes and cardiovascular disease. Our overall aim is to undertake a programme of research that improves our knowledge and understanding of screening for impaired glucose regulation and type 2 diabetes in a population with learning disabilities, and to develop a lifestyle education programme for prevention of type 2 diabetes that is suitable for use in this population.
SCREENING PROGRAMME
Aim - The main programme of work consists of a large diabetes screening programme. The primary aim of the screening study is to evaluate the feasibility and clinical and cost effectiveness of a screening programme for identifying undiagnosed type 2 diabetes and impaired glucose regulation that is suitable for use in a population with learning disabilities.
Methods - A variety of approaches will be used to recruit people to the screening study: General practices will be approached first for participation in this study. If the practice does not agree, then the investigators will seek to approach eligible people on the Leicestershire Learning Disabilities Register. Learning disabilities consultants will also approach people face to face when attending for outpatient clinic appointments. Additionally, if individuals with learning disabilities (and/or their carer) contact the STOP Diabetes team to express an interest in the study, they will be given an invitation.
- Volunteers will be asked to attend an appointment(s) where consent will be obtained and biomedical and demographic data collected. The consent process and data collection will be staged and people may need to attend between one to three appointments to complete.
- People who are found to have type 2 diabetes or impaired glucose regulation will be asked to see their GP for care.
- At every stage, reasonable adjustments will be made to take into account people's communication needs and decision making capacity. This may include involving a carer or a
DEVELOPMENT AND TESTING OF A STRUCTURED EDUCATION PROGRAMME
The aims of additional work being carried out alongside the screening study are to: (1) develop a lifestyle education programme to meet the needs of a population with learning disabilities and impaired glucose regulation or high risk of diabetes; (2) assess the feasibility of collecting outcome measures for participants with learning disabilities before and 3-months after they attend the education programme.
Methods - People approached to take part will be people who took part in the screening study and (1) gave their consent to be approached to take part in further phases of the research programme, and (2) were found to be at increased risk of developing diabetes according to their screening results.
Qualitative Interviews to inform curriculum development:
- Interviews will be conducted with a sample of people with mild/moderate learning disabilities, their carers and healthcare professionals. Findings from the interviews will help inform development of an initial curriculum and education program.
Delivery of initial curriculum and obtaining feedback:
- As part of the development work the education programme will be piloted with at least two groups of 6 - 8 people plus carers. Feedback will be collected from some of the people who attend the education sessions and any necessary changes made to the curriculum. These cycles of piloting, collecting feedback and modifying the programme will be repeated until the education programme developed is "fit for purpose".
Delivery of programme with collection of before and after measures:
- Following initial development, testing and refinement of the curriculum, the education programme will be delivered with another sample of participants and the feasibility of collecting pre and post intervention outcome measures will be tested. The investigators anticipate delivering the programme to up to two groups of 6 - 8 people plus carers. Data will be collected at baseline and 3-months (12 weeks) following delivery of the final education session. Data and may include: physical activity and sedentary behaviour (as measured by accelerometer); body weight, BMI, waist circumference, blood pressure and dietary intake (fruit and vegetables). Uptake of the education programme (attendance) and retention at 3-months follow-up will also be explored. This phase will be subject to modification depending on the findings from prior iterations and any problems encountered.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a learning (intellectual) disability who are live in Leicester, Leicestershire or Rutland, UK;
Key inclusion criteria (3 listed)
- Volunteer has a confirmed learning disability (permanent intellectual impairment);
- Registered with a general practice in Leicester, Leicestershire or Rutland, UK;
- Participant and/or carer has sufficient English language skills to enable fully informed consent to be obtained.
Key exclusion criteria (4 listed)
- Confirmed diagnosis of Type 2 diabetes or Type 1 Diabetes;
- Malignancy or terminal illness;
- Pregnancy or breast feeding;
- Severe systemic disease that may interfere with measurement and interpretation of HbA1c.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glycosylated haemoglobin (HbA1c)
Time frame: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
Plasma glucose
Time frame: Baseline screening appointment
Identification of type 2 diabetes, impaired glucose regulation, or normal glucose regulation
10 secondary outcomes
Physical activity levels (including sedentary behaviour)
Time frame: Baseline screening appointment
Obesity levels
Time frame: Baseline screening appointment
Blood pressure
Time frame: Baseline screening appointment
Lipids levels
Time frame: Baseline screening appointment
Dietary/nutritional intake
Time frame: Baseline screening appointment
Cardiovascular risk
Time frame: Baseline screening appointment
Health related quality of life
Time frame: Baseline screening appointment
Behavioural disorders
Time frame: Baseline screening appointment
Psychiatric disorders
Time frame: Baseline screening appointment
Depression
Time frame: Baseline screening appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Kamlesh Khunti, PhD, FRCGP principal investigator
Diabetes Research Centre, University of Leicester
Prof Sabyasachi Bhaumik, FRCPsych principal investigator
Learning Disability Service, Leicester Partnership NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Prediabetic State, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated haemoglobin (HbA1c) (time frame: Baseline screening appointment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.